ACell recently announced that it has received new FDA 510(k) clearance for several devices in its Gentrix Surgical Matrix product line.
“ACell continues to expand its presence in the hernia marketplace,” Patrick McBrayer, president and CEO of ACell, said in a press release. “This milestone from the FDA is another strategic building block in our objective to meet the needs of clinicians and patients with safe, cost-efficient and clinically effective devices for complex hernia repair.”
New indications for use for Gentrix Surgical Matrix, Gentrix Surgical Matrix Thin and Gentrix Surgical Matrix Plus have been outlined in the new clearance. In the clearance, the company received a specific indication for using the three Gentrix devices in laparoscopic applications. The company also received clearance for a new hernia device configuration to reinforce hiatal hernia repairs.
“These clearances are especially impactful in supporting the use of Gentrix Surgical Matrix devices in minimally invasive hernia repairs. Surgeons performing such repairs know that if they heal with the formation of excess scar tissue, they are at risk for devastating complications, potential re-operations and increased healthcare costs,” Dr. Hazem Elariny, medical director, said. “Additionally, if a surgeon chooses to utilize a product in the intraperitoneal fashion, the demonstrated minimal attachment to surrounding tissue makes Gentrix an ideal option in these cases.”